Implantation System for Tissue Repair

ABSTRACT

A prosthesis delivery and implantation system for tissue repair is disclosed. The implantation system includes provisions for manually applying a prosthesis to a treatment area. This system may be applied to heal any imperfections in various different types of tissue. The system also provides provisions for independently inserting two end portions of the prosthesis into tissue.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a division of U.S. Patent Publication Number US2011/0295258 A9 (U.S. application Ser. No. 11/934,737, filed Nov. 2,2007), which is a continuation-in-part of U.S. Pat. No. 7,632,313,issued Dec. 15, 2009 (U.S. application Ser. No. 11/117,704, filed Apr.29, 2005), both of which are herein incorporated by reference in theirentirety.

BACKGROUND

1. Field

The present invention relates generally to implantation systems and inparticular to a manual implantation system for tissue repair.

2. Description of Related Art

Currently, closure prostheses for repairing tears, cuts, holes or otherimperfections in tissue operate by inserting two ends of a closureprosthesis into the tissue simultaneously, in effect “stapling” theprosthesis into place. Other known systems provide two differentprostheses that include integrated stitches. Using this system, thedoctor must implant both prostheses in different locations, grasp theloose ends of the stitches and then laboriously and manually tie or knotthe stitches together. Current methods for implanting closure prostheseslack provisions to increase precision in the delivery of the prosthesisand to provide for increased control of implantation. There is a need inthe art for a design that solves many of the problems of the prior art.

SUMMARY

A method and apparatus for implanting a prosthesis for repairing tissueare disclosed. In one aspect, the invention provides a prosthesisdelivery and implantation system comprising: a delivery cannula having adistal end portion, the distal end portion of the delivery lumenconfigured for placement near a treated area; the delivery cannulahaving a delivery lumen configured to accommodate a prosthesis deliverysystem; the prosthesis delivery and implantation system including afirst delivery needle and a second delivery needle; and a spacing webdisposed between the first delivery needle and the second deliveryneedle; wherein the prosthesis delivery and implantation system isconfigured to retain and deliver the prosthesis; the prosthesis having afirst end portion, a central portion and a second end portion; the firstdelivery needle being generally hollow and having a first open channelconfigured to accommodate the first end portion of the prosthesis; thesecond delivery needle also being generally hollow and having a secondopen channel configured to accommodate the second end portion of theprosthesis; a first impact member disposed within the first open channelof the first delivery needle; wherein the impact member transfers afirst force to the first end portion of the prosthesis; a second impactmember disposed within the second open portion of the second deliveryneedle; and wherein the second impact member transfers a second force tothe second end portion of the prosthesis.

In another aspect, the first impact member and the second impact memberare rigidly associated and the two impact members can be drivengenerally simultaneously.

In another aspect, the first impact member and the second impact memberare capable of relative motion with respect to one another and whereinthe first impact member may be moved independent of the second impactmember.

In another aspect, distal motion of the first impact member displacesthe first end portion of the prosthesis distally and eventuallydisplaces the first end portion of the prosthesis from the firstdelivery needle and implants the first end portion of the prosthesisinto a tissue.

In another aspect, the central portion of the prosthesis is flexible andaccommodates relative motion between the first end portion of theprosthesis and the end portion of the prosthesis.

In another aspect, the second end portion of the prosthesis is displaceddistally away from the second delivery needle by the second impactmember after the first end portion of the prosthesis is implanted.

In another aspect, the first impact member includes a distal end portionconfigured to contact the first end portion of the prosthesis; and aproximal end portion configured to receive the first force.

In another aspect, the invention provides a method for implanting aprosthesis comprising the steps of: moving a delivery cannula intoposition near a tissue to be treated; loading the prosthesis into aprosthesis delivery and implantation system; moving the prosthesisdelivery and implantation system into a delivery lumen of a deliverycannula; moving the prosthesis delivery and implantation system near thetissue to be treated; implanting a first end portion of the prosthesisinto the tissue; and implanting a second end portion of the prosthesisinto the tissue.

In another aspect, the step of moving the prosthesis delivery andimplantation system into the delivery lumen of the delivery cannula isperformed before the step of moving the delivery cannula into positionnear the tissue.

In another aspect, the step of loading the prosthesis into a prosthesisdelivery and implantation system includes the steps of: placing a firstend portion of the prosthesis into a first open channel of a firstdelivery needle; and placing a second end portion of the prosthesis intoa second open channel of a second delivery needle.

In another aspect, further comprising the step of moving the prosthesisdistally towards the tissue.

In another aspect, wherein the prosthesis is moved distally by moving afirst impact member disposed within a first open channel of a firstdelivery needle and by moving a second impact member disposed within asecond open channel of a second delivery needle.

In another aspect, the first impact member and the second impact memberare rigidly associated and the two impact members can be drivengenerally simultaneously.

In another aspect, the first impact member and the second impact membercan be driven independently.

In another aspect, the invention provides a prosthesis delivery andimplantation system comprising: a delivery cannula having a distal endportion, the distal end portion of the delivery lumen configured forplacement near a treated area; the delivery cannula having a deliverylumen configured to accommodate a prosthesis delivery system; theprosthesis delivery and implantation system including a first deliveryneedle and a second delivery needle; and a spacing web disposed betweenthe first delivery needle and the second delivery needle; wherein theprosthesis delivery system is configured to retain and deliver theprosthesis; the prosthesis having a first end portion, a central portionand a second end portion; the first delivery needle being generallyhollow and having a first open channel configured to accommodate thefirst end portion of the prosthesis; the second delivery needle alsobeing generally hollow and having a second open channel configured toaccommodate the second end portion of the prosthesis; and wherein thefirst end portion is implanted substantially prior to the implantationof the second end portion.

In another aspect, the prosthesis is moved distally by moving a firstimpact member disposed within a first open channel of a first deliveryneedle and by moving a second impact member disposed within a secondopen channel of a second delivery needle.

In another aspect, a first force is applied to the first impact member.

In another aspect, a second force is applied to the second impact memberafter the first force has been applied to the first impact member.

In another aspect, the prosthesis may be applied to a detached tendonand reconnect the tendon to an associated bone.

In another aspect, the prosthesis may be used to repair a meniscus.

In another aspect, the prosthesis may be used to repair a tearassociated with an injury to a rotator cuff.

In another aspect, the prosthesis may be used to attach a first portionof bone to a second portion of bone.

In another aspect, the invention provides a prosthesis delivery andimplantation system comprising: a prosthesis having a first end portion,a central portion and a second end portion; a first impact member havinga first distal end configured to associate and align with the first endportion; wherein the impact member transfers a first force to the firstend portion of the prosthesis; a second impact member having a seconddistal end configured to associate and align with the second endportion; and wherein the second impact member transfers a second forceto the second end portion of the prosthesis.

In another aspect, the invention provides a method for implanting aprosthesis comprising the steps of: loading the prosthesis into aprosthesis delivery and implantation system; moving the prosthesisdelivery and implantation system near the tissue to be treated;implanting a first end portion of the prosthesis into the tissue; andimplanting a second end portion of the prosthesis into the tissue.

Other systems, methods, features and advantages of the invention willbe, or will become apparent to one with skill in the art uponexamination of the following figures and detailed description. It isintended that all such additional systems, methods, features andadvantages be included within this description, be within the scope ofthe invention, and be protected by the following claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention can be better understood with reference to the followingdrawings and description. The components in the figures are notnecessarily to scale, emphasis instead being placed upon illustratingthe principles of the invention. Moreover, in the figures, likereference numerals designate corresponding parts throughout thedifferent views.

FIG. 1 is a plan view of a preferred embodiment of a prosthesis deliveryand implantation system;

FIG. 2 is an isometric view of a preferred embodiment of a prosthesisdelivery and implantation system;

FIG. 3 is a schematic view of a preferred embodiment of a deliverycannula associating with a treatment area;

FIG. 4 is a cross sectional view of a preferred embodiment of aprosthesis delivery and implantation system associating with a firsttissue and a second tissue;

FIG. 5 is a cross sectional view of a preferred embodiment of a firstimpact member of a prosthesis delivery and implantation systemdelivering a first force to a first end portion of a prosthesis;

FIG. 6 is a cross sectional view of a preferred embodiment of a secondimpact member of a prosthesis delivery and implantation systemdelivering a second force to a second end portion of a prosthesis;

FIG. 7 is a cross sectional view of a preferred embodiment of aprosthesis fully implanted into a first tissue and a second tissue;

FIG. 8 is a cross sectional view of a preferred embodiment of aprosthesis delivery and implantation system with delivery needlespenetrating through a first tissue and a second tissue;

FIG. 9 is a cross sectional view of a preferred embodiment of two impactmembers of a prosthesis delivery and implantation system deliveringforces to end portions of a prosthesis;

FIG. 10 is a schematic view of a preferred embodiment of a prosthesisconfigured to attach a first portion of a bone to a bone structure;

FIG. 11 is a schematic view of a preferred embodiment of a prosthesisconfigured to attach to a first fractured portion of a bone and a secondfractured portion of a bone prior to implantation;

FIG. 12 is a schematic view of a preferred embodiment of a prosthesisconfigured to attach to a first fractured portion of a bone and a secondfractured portion of a bone post implantation;

FIG. 13 is top down isometric view of a preferred embodiment of aprosthesis configured to repair a circumferential tear in a medialmeniscus in a pre-operating condition;

FIG. 14 is a top down view of a preferred embodiment of a prosthesisconfigured to repair a circumferential tear in a medial meniscus is apost-operating condition;

FIG. 15 is top down isometric view of a preferred embodiment of aprosthesis configured to repair a radial tear in a medial meniscus in apre-operating condition;

FIG. 16 is a top down view of a preferred embodiment of a prosthesisconfigured to repair a radial tear in a medial meniscus is apost-operating condition;

FIG. 17 is a plan view of a preferred embodiment of a prosthesisconfigured to attach a tendon to a humerus bone in a pre-operatingcondition; and

FIG. 18 is a plan view of a preferred embodiment of a prosthesisconfigured to attach a tendon to a humerus bone in a post-operatingcondition.

DETAILED DESCRIPTION

FIGS. 1-2 illustrate one embodiment of prosthesis delivery andimplantation system 100, hereby referred to as PDI system 100.Specifically, FIG. 1 is a plan view of a preferred embodiment of PDIsystem 100 and FIG. 2 is an exploded isometric view of a preferredembodiment of PDI system 100. Generally, PDI system 100 may be used forrepairing any flaw, imperfection, cut, incision, hole, or tear invarious types of tissue throughout the human body. The term “tissue” asused throughout this detailed description and in the claims refers toany collection of interconnected cells that perform a similar functionwithin an organism. Examples of different types of biological tissueinclude epithelium, connective tissue (such as bone), muscle tissue andnervous tissue.

In this embodiment, PDI system 100 may be associated with deliverycannula 101. Generally, delivery cannula 101 may be any type of tubethat is configured to insert into the body and may include one or morechannels for delivering one or more devices. In this preferredembodiment, delivery cannula 101 includes delivery lumen 102 foraccommodating PDI system 100. Delivery cannula 101 and delivery lumen102 preferably both include distal end portion 152 that is configured tobe placed near a treatment area of one or more tissues.

PDI system 100 preferably comprises several components configured todeliver and implant prosthesis 200 into some kind of tissue in need ofrepair. Although one particular embodiment of prosthesis 200 isillustrated in these figures, the size, shape, and other characteristicsof the individual components comprising prosthesis 200 may be determinedbased on a number of factors, potentially including the size and shapeof the imperfection; the condition and type of tissue that may berepaired using prosthesis 200; and the type and amount ofcircumferential or other stress that is to be exerted by prosthesis 200on the surrounding tissue during the implantation process.

Prosthesis 200 may comprise first end portion 202 and second end portion204 that are joined by central portion 206. End portions 202 and 204each include relatively pointed ends 208. Along the length of the endportions 202 and 204 behind pointed ends 208 are a number of projections212 that extend inwardly and rearwardly, such that their free endsgenerally point towards central portion 206. Although only a fewprojections 212 are shown in FIGS. 1 and 2, in other embodiments,prosthesis 200 may include any number of projections 212, arranged overall or part of prosthesis 200, including both first and second endportions 202, 204 and connecting portion 206. In still otherembodiments, projections 212 can also be arranged in different planes.

In some embodiments, pointed ends 208 may also anchor prosthesis 200.For example, the relatively larger back portion 214 of pointed ends 208may also help to anchor end portions 202 and 204 of prosthesis 200. Inother embodiments, pointed ends 208 could have a different shape that isconfigured to facilitate implantation and anchoring of prosthesis 200.

Central portion 206 of prosthesis 200 extends between first end portion202 and second end portion 204 and connects first end portion 202 withsecond end portion 204. In some embodiments, central portion 206 mayprovide a rigid connection between end portions 202 and 204. In otherembodiments, however, central portion 206 may be flexible and configuredto allow for relative motion of first end portion 202 with respect tosecond end portion 204. In some cases, central portion 206 may be pulledtaut between end portions 202 and 204. In other cases, central portion206 can be partially slack between end portions 202 and 204.

Further examples of prostheses of the type discussed here can be foundin U.S. 2006/0247643, which is hereby incorporated by reference.

PDI system 100 also preferably includes first delivery needle 106 andsecond delivery needle 108. In this embodiment, delivery needles 106 and108 may disposed within delivery lumen 102. In some embodiments,delivery needles 106 and 108 are generally hollow. In a preferredembodiment, delivery needles 106 and 108 may be partially opened. Inparticular, first delivery needle 106 may include first open channel107. Also, second delivery needle 108 may include second open channel109. In a preferred embodiment, channels 107 and 109 have C-shaped crosssections. The C-shaped cross section of second open channel 109 can beclearly seen in FIG. 2. Preferably, first open channel 107 has a similarC-shaped cross section. With this configuration, open channels 107 and109 are configured to receive prosthesis 200 in a manner that allowsprosthesis 200 to slide between delivery needles 106 and 108 whileallowing first end portion 202 and second end portion 204 to bepartially restrained within first delivery needle 106 and seconddelivery needle 108, respectively.

Delivery needles 106 and 108 may also include tapered ends configured tocontact, and some cases penetrate through tissue. In this embodiment,first delivery needle 106 and second delivery needle 108 may includefirst needle end 120 and second needle end 122, respectively. In apreferred embodiment, needle ends 120 and 122 are tapered to providesharpened tips. In some cases, this tapered configuration of needle ends120 and 122 may provide for wider openings of open channels 107 and 109.

In some embodiments, delivery needles 106 and 108 may be connected viaspacing web 110 disposed between delivery needles 106 and 108. In somecases, spacing web 110 may be attached to delivery needles 106 and 108on outer surfaces of delivery needles 106 and 108 that are disposed awayfrom open channels 107 and 109. This arrangement preferably helpsprevent spacing web 110 from interfering with one or more componentsdisposed within open channels 107 and 109.

In some cases, spacing web 110 may provide for a rigid connectionbetween delivery needles 106 and 108. In other cases, spacing web 110may provide for a loose connection between delivery needles 106 and 108.With this arrangement, spacing web 110 may be configured to preventdelivery needles 106 and 108 from separating beyond a predetermineddistance that would allow prosthesis 200 to slide out of open channels107 and 109.

Preferably, PDI system 100 includes provisions for applying a force toprosthesis 200 for implantation into various types of tissue. In someembodiments, PDI system 100 may be associated with first impact member130 and second impact member 132. Impact members 130 and 132 arepreferably configured to insert into open channels 107 and 109. In apreferred embodiment, impact members 130 and 132 are substantially rigidand configured to transfer a force applied at first proximal end portion140 and second proximal end portion 141 to first distal end portion 142and second distal end portion 143, respectively. With this arrangement,impact members 130 and 132 may be used to transfer an insertion force tofirst end portion 202 and second end portion 204 of prosthesis 200. Inparticular, first impact member 130 may transfer a first force to firstend portion 202 and second impact member 132 may transfer a second forceto second end portion 204.

In some embodiments, first impact member 130 and second impact member132 may be rigidly connected using one or more connecting members.Provisions for connecting impact members 130 and 132 are discussedbelow. This may help apply forces to end portions 202 and 204simultaneously. In other embodiments, impact members 130 and 132 may notbe rigidly attached and may be capable of relative motion with respectto one another. In these embodiments, a force must be applied to eachimpact member 130 and 132 separately to implant end portions 202 and204.

Generally, various different types of materials may be used for makingPDI system 100. Preferably, delivery needles 106 and 108 may be made ofrigid materials. Likewise, impact members 130 and 132 may also be madeof rigid materials. In some cases, rigid plastics may be used. In othercases, materials may be used that include some type of metal.

In some embodiments, portions of prosthesis 200 may be made of agenerally rigid material. Other portions of prosthesis 200 may be madeof a generally flexible material. In a preferred embodiment, endportions 202 and 204 are made of a generally rigid material and centralportion 206 is made of a generally flexible material. Using a rigidmaterial may help facilitate insertion of prosthesis 200 into varioustypes of tissue. In some cases, prosthesis 200 could be made of amaterial including metal. In other embodiments, however, prosthesis 200could be made of other materials. In other cases, for example, it may bepreferable to make prosthesis 200 using a biocompatible material that issufficiently rigid to hold a cut or incision in some types of tissueclosed, yet sufficiently compliant so as to avoid further damaging thetissue should slight relative motion between the tissue and prosthesis200 occur. Examples of suitable materials include nylon, prolene,dacron, ultra high molecular weight polyethylene (UHMWPE), and othersuitable suture materials. In a preferred embodiment, prosthesis 200 maybe made of a material including at least one type of metal.

In still other embodiments, prosthesis 200 may be formed of abioabsorbable polymer that is gradually absorbed by the body. Someexamples of suitable bioabsorbable materials are: poly L-lactic acid(PLLA), polyglycolic acid (PGA). Closure prosthesis can also be formedof other possible materials, including polytetrafluorethylene (PTFE),polyaryletherketone (PAEK), polyetheretherketone (PEEK),polyoxymethylene (acetal), polycarbonate, polysulfone, siliconeelastomers, commercially pure titanium, titanium alloys, CoCr alloys,nickel titanium (nitinol) alloys and implant grade stainless steels.

Referring to FIGS. 1 and 2, assembly of PDI system 100 may begin byloading prosthesis 200 into delivery needles 106 and 108. In particular,first end portion 202 may be inserted into first open channel 107.Likewise, second end portion 204 may be inserted into second openchannel 109. Following this, impact members 130 and 132 may be insertedinto open channels 107 and 109, respectively. At this point, PDI system100, including delivering needles 106 and 108 as well as impact members130 and 132 and prosthesis 200 may be inserted into delivery lumen 102.Generally, delivery needles 106 and 108 may be inserted through deliverylumen 102 until needle ends 120 and 122 are disposed just within distalend portion 152 of delivery lumen 102. As seen in FIG. 1, distal endportions 142 and 143 of impact members 130 and 132, respectively,preferably extend out of proximal end portion 150 of delivery lumen 102.It should be understood that the order of assembling the components ofPDI system 100 is intended to be exemplary. In other embodiments, theorder of assembly may vary. Additionally, it should be understood thatPDI system 100 may be associated with a delivery cannula at varioustimes. In some cases, PDI system 100 may be inserted into the deliverylumen of the delivery cannula prior to moving the delivery cannula intoposition near a tissue to be treated. In other case, PDI system 100 maybe inserted into the delivery lumen after moving the delivery cannulainto position near the tissue to be treated.

FIGS. 3-8 illustrate a method of implanting prosthesis 200 using PDIsystem 100 in order to reattach first tissue 300 to second tissue 302.The current embodiment is intended to be generic and could be applied tovarious different situations in which one tissue must be reattached to asecond tissue. For example, in some cases, first tissue 300 may be atendon and second tissue 302 may be a bone. In this case, second tissue302 could be any bone in the body and first tissue 300 could be anyassociated tendon configured to attach to second tissue 302. In othercases, first tissue 300 and second tissue 302 could be similar types oftissue.

Generally, delivery cannula 101 may be inserted into an incision of apatient. Throughout the remainder of this detailed description it shouldbe understood that this method for repairing tissue using PDI system 100may include various additional steps often associated with arthroscopicsurgery. In some embodiments, an arthroscope or similar device may beinserted into a second incision in the skin of the patient. With thisarrangement, a surgeon may visualize the tissue requiring repair throughvideo taken with the arthroscope.

Referring to FIG. 3, delivery cannula 101 may initially be disposed intreated area 301. The term “treated area” as used through this detaileddescription and in the claims refers to the region of a tissue that maybe repaired using PDI system 100. Using distal end portion 152 ofdelivery cannula 101, first tissue 300 may be pressed against secondtissue 302 to set first tissue 300 in place prior to implantation.Preferably, at this point, delivery needles 106 and 108 are disposedjust within distal end portion 152 so that delivery cannula 101 presentsa generally blunt surface to first tissue 300. This may help prevent anytearing of first tissue 300 with PDI system 100.

Referring to FIG. 4, delivery needles 106 and 108 may be displaced fromdistal end portion 152 of delivery lumen 102. In some embodiments,needle ends 120 and 122 may be used to precisely locate PDI system 100on second tissue 302. In some cases, needle ends 120 and 122 may providepoints of contact between PDI system 100 and second tissue 302 tosubstantially reduce any movement of PDI system 100 with respect tosecond tissue 302. In this preferred embodiment, needle ends 120 and 122do not substantially pierce second tissue 302 and only contact outersurface 303 of second tissue 302. However, needle ends 120 and 122 maypierce through first tissue 300 at first portion 310 and second portion312.

In an alternative embodiment, seen in FIG. 8, needle ends 120 and 122may penetrate into second tissue 302. Generally, needle ends 120 and 122may penetrate by any desired amount. In some embodiments, needle ends120 and 122 may penetrate into second tissue 302 a distance D1 belowouter surface 303. In some cases, the value of distance D1 may vary inthe range between 1 millimeter and 2 centimeters. In certainembodiments, the value of distance D1 is approximately 1 centimeter.With this arrangement, needle ends 120 and 122 may help facilitate thepenetration of prosthesis 200 into second tissue 302 by creating holesin which end portions 202 and 204 or prosthesis 200 may be inserted.

Referring to FIGS. 5 and 6, it may be preferable to drive end portions202 and 204 into tissues 300 and 302 independently. In this case, tool500 may be used to apply a first force to first impact member 130. Asfirst impact member 130 is driven distally through first open channel107, first distal end portion 142 of first impact member 130 may beconfigured to drive first end portion 202 through tissues 300 and 302.As seen in FIG. 5, second end portion 204 of prosthesis 200 remains inplace since second impact member 132 does not move and central portion206 deforms without transferring force to second end portion 204.

Referring now to FIG. 6, tool 500 may be used to apply a second force tosecond impact member 132. As second impact member 132 is driven distallythrough second open channel 109, second distal end portion 143 of secondimpact member 132 may be configured to drive second end portion 204 ofprosthesis 200 through tissues 300 and 302. As seen in FIG. 6, first endportion 202 of prosthesis 200 remains in place since first impact member132 does not move at this point and central portion 206 can deformwithout transferring force to first end portion 202. Preferably, theprocess illustrated in FIGS. 5 and 6 is repeated until both end portions202 and 204 are fully implanted. With this arrangement, first endportion 202 may be implanted substantially prior to the implantation ofsecond end portion 204 rather than simultaneously with second endportion 204.

By applying a first force to first impact member 130, the distal motionof first impact member 130 displaces first end portion 202 of prosthesis200 distally and eventually displaces first end portion 202 from firstdelivery needle 106. At this point, first end portion 202 may be fullyimplanted into tissues 300 and 302. Also, by applying a second force tosecond impact member 130, the distal motion of second impact member 132displaces second end portion 204 of prosthesis 200 and eventuallydisplaces second end portion 204 form second delivery needle 108. Atthis point, second end portion 202 may be fully implanted into tissues300 and 302. As previously discussed, projections 212 may facilitateanchoring end portions 202 and 204 as prosthesis 200 is implanted intosecond tissue 302.

Using this arrangement, first end portion 202 and second end portion 204may be driven into tissues 300 and 302 independently, to provide forincreased control over the implantation of prosthesis 200. This methodmay be advantageous over prior methods that require implantation of twoends of a prosthesis simultaneously. Additionally, because centralportion 206 is partially deformable, end portions 202 and 204 could bedriven to slightly different depths within second tissue 302 by applyingdifferent forces to first impact member 130 and second impact member132.

In an alternative embodiment, seen in FIG. 9, impact members 130 and 132may be rigidly attached using connecting member 136. In this embodiment,connecting member 136 may be a cap that slides over impact members 130and 132 at proximal end portions 140 and 141, respectively. In otherembodiments, a connecting member could include a fastener that can bedisconnected to allow impact members 130 and 132 to move independentlyof one another. For example, in other embodiments, the connecting membercould include a hinge. In still other embodiments, other mechanisms forattaching and detaching impact members 130 and 132 could also be used.

Using connecting member 136, a driving force may be applied to impactmembers 130 and 132 simultaneously. In this alternative embodiment,impact members 130 and 132 are rigidly attached via connecting member136. As a driving force is applied to connecting member 136 and impactmembers 130 and 132 using tool 500, impact members 130 and 132 areconfigured to move in a distal direction through open channels 107 and109. In particular, distal end portions 142 and 143 are configured toimpact first end portion 202 and second end portion 204 of prosthesis200. This impact helps to drive end portions 202 and 204 of prosthesis200 distally through first tissue 300 and into second tissue 302.Preferably, the driving force provided by tool 500 may be reapplied manytimes until first end portion 202 and second end portion 204 are fullydriven into second tissue 302. As previously discussed, projections 212may facilitate anchoring end portions 202 and 204 as prosthesis 200 isimplanted into second tissue 302.

Referring to FIG. 7, following the implantation of prosthesis 200, PDIsystem 100 may be removed from treatment area 301. As seen in thisFigure, first portion 310 of first tissue 300 has been attached tosecond tissue 302 by first end portion 202 of prosthesis 200. Likewise,second portion 312 of first tissue 300 has been attached to secondtissue 302 by second end portion 204 of prosthesis 200. With thisarrangement, first tissue 300 may be fixedly attached to second tissue302 to help facilitate healing of treatment area 301.

Preferably, prosthesis 200 is also configured to hold additionalportions of tissue 300 in place with respect to second tissue 302. Inthis embodiment, first tissue 300 further includes intermediate portion314 that is disposed between first portion 310 and second portion 312.As end portions 202 and 204 are implanted into second tissue 302,central portion 206 may be configured to wrap around a portion ofintermediate portion 314. As previously discussed, central portion 206is configured to be flexible and preferably generally conforms to theshape of intermediate portion 314. Furthermore, end portions 202 and 204may apply tension to central portion 206 that may be used to tightlyfasten intermediate portion 314 in place. With this arrangement,multiple portions of first tissue 300 may be fixed in place with respectto second tissue 302 without the use of additional end portions forimplantation through tissues 300 and 302. In some cases, thisarrangement may help maintain a strong connection between tissues 300and 302.

In some embodiments, a PDI system may be operated without the use of acannula. For example, in some cases a surgeon may repair a portion oftissue that is disposed close to the surface of the skin, such as a boneor tendon in a foot or a hand. In this case, the PDI system, includingfirst and second driving needles, first and second impact members and aprosthesis, may be directly associated with the tissue without the useof a cannula. In particular, the driving needles may be located at thetreatment area and the impact members may be used to drive theprosthesis into the tissue.

In another embodiment, a prosthesis may be implanted without the use ofa set of delivery needles. Instead, a set of impact members may beconfigured to align with portions of the first end portion and thesecond end portion of the prosthesis using other provisions. In somecases, for example, a distal portion of an impact member could associatewith an end portion of a prosthesis using a magnetic coupling. In othercases, the impact member could be associated with the end portion usinga light adhesive. In still other cases, other types of provisions couldbe used to associate and align an impact member with an end portion of aprosthesis. Using this arrangement, a first impact member may include afirst distal portion that may be configured to align and associate witha first end portion of a prosthesis. Likewise, a second impact membermay include a second distal portion that may be configured to align andassociate with a second end portion of the prosthesis. With thisarrangement, the first and second impact members may be used to drivethe first and second end portions of the prosthesis directly into one ormore tissues without the use of delivery needles.

FIGS. 10-18 are intended to illustrate specific examples of tissuesystems that may be repaired using PDI system 100. It should beunderstood that the following embodiments are not intended to belimiting and other uses for PDI system 100 would be apparent to anyoneskilled in the art. As previously discussed, PDI system 100 may be usedwith any type of tissue that requires repair and that is configured toreceive prosthesis 200. Furthermore, the following embodimentsillustrate various applications of prosthesis 200 to tissue systems anddo not include steps for implanting prosthesis 200 which have alreadybeen discussed in the previous embodiments. It should be understood thatin each of the following examples, prosthesis 200 can be implanted intoone or more tissues using PDI system 100 by following stepssubstantially similar to those previously discussed.

In some embodiments, PDI system 100 may be used for attaching a portionof bone that has broken away from a bone structure. In some cases, PDIsystem 100 may be used to implant end portions 202 and 204 of prosthesis200 through the portion of bone and into the bone structure. In othercases, PDI system 100 could be used to implant end portions 202 and 204of prosthesis only into the bone structure in a manner that holds theportion of bone in place with respect to the bone structure usingcentral portion 206 of prosthesis 200. In a preferred embodiment, PDIsystem 100 may be used to deliver and implant end portions 202 and 204of prosthesis 200 into the portion of bone and the bone structure andalso may apply tension to the substantial entirety of the portion ofbone with central portion 206.

Referring to FIG. 10, prosthesis 200 may be used to repair tissue system900 that comprises bone 902 and portion of bone 904. In this case,portion of bone 904 has fractured off of bone 902 and requiresreattachment. In this embodiment, first end portion 202 and second endportion 204 have been implanted through portion of bone 904 and bone 902using PDI system 100 in order to facilitate healing. In particular,first end portion 202 has been inserted through first portion 920 ofportion of bone 904 and second end portion 202 has been inserted throughsecond portion 922 of portion of bone 904. Additionally, central portion206 has conformed to, and applied tension across, intermediate portion924 of portion of bone 904. With this arrangement, prosthesis 200 isconfigured to facilitate the reattachment of portion of bone 904 to bone902 to repair tissue system 900.

Referring to FIGS. 11-12, prosthesis 200 may also be used to help repairfirst fractured end 1002 and second fractured end 1004 of bone 1000 thathave separated, or to fuse two adjacent bones 1002 and 1004. Asindicated schematically, prosthesis 200 may be applied to firstfractured end 1002 and second fractured end 1004 using PDI system 100.In this case, first end portion 202 may be configured to implant intofirst fractured end 1002. Likewise, second end portion 204 may beconfigured to implant into second fractured end 1004. With thisarrangement, first fractured end 1002 and second fractured end 1004 maybe secured against one another under the tension of central portion 206.As fractured ends 1002 and 1004 are fixed in place using prosthesis 200,new bone growth between ends 1002 and 1004 may help permanently repairbone 1000.

Referring to FIGS. 13-16, prosthesis 200 may be used to repair one ormore portions of meniscus 1100. FIG. 13 illustrates a preferredembodiment of a meniscus 1100 with circumferential tear 1102 in apre-operative state. In some cases, prosthesis 201 may be applied in anaxial or vertical direction to circumferential tear 1102. In a preferredembodiment, prosthesis 200 may be applied along interior portion 1104 ofmeniscus 1100 in order to facilitate the repair of circumferential tear1102. FIG. 14 illustrates meniscus 1100 in a post-operative state. Inthis case, prosthesis 200 has been applied radially acrosscircumferential tear 1102 and meniscus 1100 may be allowed to heal.Additionally, in this embodiment, prosthesis 201 has been applied overcircumferential tear 1102 in an axial direction.

Referring to FIGS. 15-16, prosthesis could also be applied to meniscus1150 that requires repair for radial tear 1152. FIG. 15 shows meniscus1150 with radial tear 1152 in a pre-operative state, before prosthesis200 has been applied using PDI system 100. In FIG. 16, prosthesis 200has been applied to repair radial tear 1152. In particular, first endportion 202 and second end portion 204 are disposed on opposing sides ofradial tear 1152. With this arrangement, radial tear 1152 may be pinchedtogether and allowed to heal.

Referring to FIGS. 17 and 18, prosthesis 200 may be applied to tendon1202 that has detached from humerus 1204. This situation is common inrotator cuff injuries. FIG. 17 illustrates detached tendon 1202 in apre-operative state. FIG. 18 illustrates tendon 1202 attached to humerus1204 in a post-operative state using prosthesis 200. In particular,first end portion 202 and second end portion 204 of prosthesis 200 havepreferably inserted through tendon 1202 and been implanted into humerus1204.

For clarity, the previous embodiments illustrated in FIGS. 11-18 onlyshow the use of a single prosthesis to repair different types of tissue.It should be understood that in other embodiments, any number ofprosthesis could be applied simultaneously to repair one or moretissues. For example, in some cases, two prostheses could be used torepair a tissue. In other cases, more than two prostheses could be usedto repair a tissue. Additionally, any shapes and/or orientations of oneor more prostheses may be used in other embodiments. For example, insome cases an X-shaped configured of two prostheses could be used. Inother embodiments, various other types of geometric shapes or patternsmay be formed using multiple prostheses. Using multiple prostheses invarious shapes and patterns may allow a surgeon to obtain the desiredtension and attachment configuration for the prostheses to promotehealing of the damaged tissue.

While various embodiments of the invention have been described, thedescription is intended to be exemplary, rather than limiting and itwill be apparent to those of ordinary skill in the art that many moreembodiments and implementations are possible that are within the scopeof the invention. Accordingly, the invention is not to be restrictedexcept in light of the attached claims and their equivalents. Also,various modifications and changes may be made within the scope of theattached claims.

What is claimed is:
 1. A prosthesis delivery and implantation systemcomprising: a delivery cannula having a distal end portion, the distalend portion of the delivery cannula configured for placement near atreated area; the delivery cannula having a delivery lumen; a prosthesisdelivery system disposed in the delivery cannula; the prosthesisdelivery system including a first delivery needle, a second deliveryneedle, and a spacing web connecting the first delivery needle to thesecond delivery needle; a prosthesis having a first end portion, acentral portion, and a second end portion; wherein the prosthesisdelivery system is configured to retain and deliver the prosthesis; thefirst delivery needle being generally hollow and having a first openchannel in which the first end portion of the prosthesis is disposed;the second delivery needle being generally hollow and having a secondopen channel in which the second end portion of the prosthesis isdisposed; a first impact member disposed within the first open channelof the first delivery needle; wherein the first impact member transfersa first force to the first end portion of the prosthesis; a secondimpact member disposed within the second open portion of the seconddelivery needle; and wherein the second impact member transfers a secondforce to the second end portion of the prosthesis.
 2. The systemaccording to claim 1, wherein the first impact member and the secondimpact member are rigidly associated such that the first impact memberand the second impact member are capable of being driven generallysimultaneously.
 3. The system according to claim 1, wherein the firstimpact member and the second impact member are capable of relativemotion with respect to one another and wherein the first impact membermay be moved independently of the second impact member.
 4. The systemaccording to claim 1, wherein distal motion of the first impact memberdisplaces the first end portion of the prosthesis distally andeventually displaces the first end portion of the prosthesis out of thefirst delivery needle and implants the first end portion of theprosthesis into a tissue.
 5. The system according to claim 4, whereinthe central portion of the prosthesis is flexible to accommodaterelative motion between the first end portion of the prosthesis and thesecond end portion of the prosthesis.
 6. The system according to claim5, wherein the second end portion of the prosthesis is displaceddistally away from the second delivery needle by the second impactmember after the first end portion of the prosthesis is implanted. 7.The system according to claim 1, wherein the first impact memberincludes a distal end portion and a proximal end portion opposite to thedistal end portion, wherein the distal end portion contacts the firstend portion of the prosthesis, and wherein the proximal end portionreceives the first force.
 8. The system according to claim 1, whereinthe central portion of the prosthesis is deformable such that thecentral portion deforms a first time while implanting the first endportion independently of the second end portion and a second time whileimplanting the second end portion independently of the first endportion.
 9. The system according to claim 1, further comprising adisconnectable connecting member that rigidly connects the first impactmember to the second impact member.
 10. The system according to claim 9,wherein the disconnectable connecting member comprises a cap disposedover a proximal end of the first impact member and a proximal end of thesecond impact member.
 11. The system according to claim 9, wherein thedisconnectable connecting member comprises a hinged disconnectableconnecting member.
 12. The system according to claim 1, wherein thefirst and second delivery needles hold the respective first and secondimpact members apart from each other at a fixed distance lateral to animplantation direction.
 13. The system according to claim 1, wherein thefirst open channel of the first delivery needle defines a firstlongitudinal axis; wherein the second open channel of the seconddelivery needle defines a second longitudinal axis; wherein the firstend portion of the prosthesis has a first distal anchor portion thatprojects from a remainder of the first end portion in a directionlateral to the first longitudinal axis so as to define a first impactsurface; wherein the second end portion of the prosthesis has a seconddistal anchor portion that projects from a remainder of the second endportion in a direction lateral to the second longitudinal axis so as todefine a second impact surface; wherein the first impact membertransfers the first force to the first end portion of the prosthesis bypushing against the first impact surface; and wherein the second impactmember transfers the second force to the second end portion of theprosthesis by pushing against the second impact surface.
 14. The systemaccording to claim 13, wherein each of the first and second distalanchor portions is cylindrical and each of the first and second impactsurfaces is circular.
 15. The system according to claim 14, wherein anend of the first distal anchor portion opposite to the first impactsurface is pointed, and wherein an end of the second distal anchorportion opposite to the second impact surface is pointed.
 16. The systemaccording to claim 15, wherein the remainder of the first end portionhas at least one first projection; wherein the remainder of the secondend portion has at least one second projection; wherein when theprosthesis is disposed in the first and second delivery needles: thefirst end portion of the prosthesis is generally parallel to the secondend portion of the prosthesis; the central portion of the prosthesis isgenerally transverse to the first end portion and the second endportion; and the at least one first projection and the at least onesecond projection extend toward each other and distally toward thecentral portion of the prosthesis.
 17. A prosthesis delivery andimplantation system comprising: a delivery cannula having a distal endportion, the distal end portion of the delivery cannula configured forplacement near a treated area; the delivery cannula having a deliverylumen; a prosthesis delivery system disposed in the delivery cannula;the prosthesis delivery system including a first delivery needle, asecond delivery needle, and a spacing web disposed between the firstdelivery needle and the second delivery needle; a prosthesis having afirst end portion, a central portion, and a second end portion; whereinthe prosthesis delivery system is configured to retain and deliver theprosthesis; the first delivery needle being generally hollow and havinga first open channel configured to accommodate the first end portion ofthe prosthesis; the second delivery needle being generally hollow andhaving a second open channel configured to accommodate the second endportion of the prosthesis; and wherein the prosthesis delivery systemallows the first end portion to be implanted substantially prior to theimplantation of the second end portion.
 18. The system according toclaim 17, wherein the prosthesis is moved distally by moving a firstimpact member disposed within a first open channel of the first deliveryneedle and by moving a second impact member disposed within a secondopen channel of the second delivery needle.
 19. The system according toclaim 18, wherein the first impact member and the second impact membermove independently of each other, such that the first impact membermoves in response to a first force applied to the first impact member,and the second impact member subsequently moves in response to a secondforce applied to the second impact member after the first force has beenapplied to the first impact member.
 20. The system according to claim17, wherein the central portion of the prosthesis is deformable suchthat the central portion deforms a first time while implanting the firstend portion independently of the second end portion and a second timewhile implanting the second end portion independently of the first endportion.
 21. The system according to claim 17, wherein the firstdelivery needle and the second delivery needle are generally linear andare positioned generally parallel to each other; wherein the first openchannel of the first delivery needle comprises a C-shaped channel opentoward the second delivery needle; and wherein the second open channelof the second delivery needle comprises a C-shaped channel open towardthe first delivery needle.
 22. The system according to claim 21, whereinthe spacing web is attached to outer surfaces of the first and seconddelivery needles clear of the first and second open channels and theprosthesis.
 23. The system according to claim 17, wherein the prosthesisis configured to at least one of: attach a tendon to an associated bone,attach a first portion of bone to a second portion of bone, repair ameniscus, and repair a torn rotator cuff.
 24. A prosthesis delivery andimplantation system comprising: a prosthesis having a first end portion,a central portion, and a second end portion; wherein the central portionis deformable and wherein the first and second end portions are morerigid than the central portion; a first impact member having a firstdistal end configured to associate and align with the first end portion;a second impact member having a second distal end configured toassociate and align with the second end portion; wherein, at a firsttime, the first impact member moves in an implantation direction andapplies a first force to the first end portion of the prosthesis, whilethe second impact member remains substantially stationary; wherein, at asecond time subsequent to the first time, the second impact member movesin the implantation direction and applies a second force to the secondend portion of the prosthesis, while the first impact member remainssubstantially stationary; and wherein the central portion of theprosthesis deforms during a period between the first time and the secondtime.